Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Summary
The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.
Detailed description
This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.
Arms & interventions
- DeviceTwo photon fluorescence microscopy imaging
Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.
Outcome measures
Primary
Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology
The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated.
Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Secondary
Overall agreement on margin status
Time frame: Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery
Eligibility criteria
Study locations (1)
Rochester Dermatologic Surgery
Victor, New York, 14654
References
- Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.(PubMed)